NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
SBIR/STTR Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This
FOA must be read in conjunction with the application guidelines included with
this announcement in Grants.gov/Apply for
Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and
applicants are highly encouraged to start the process at least four (4) weeks
prior to the grant submission date. See Section IV.

Purpose..Tools for germplasm
cryopreservation have become increasingly important in enabling repositories to
meet the needs for establishing banks of animal germplasm for current and
future research needs. This funding opportunity announcement (FOA) solicits
applications from small business concerns (SBCs) for Small Business Technology
Transfer (STTR) projects that propose innovative research in the areas of
animal germplasm cryopreservation methods, reagents, equipment, biosecurity,
and the detection of disease, including the vertical transmission of disease. (See more
information listed in Section I. Funding Opportunity
Description ).

Mechanism of Support.This FOA will utilize the STTR (R41/R42) grant
mechanisms for Phase I, Phase II, and Fast-Track applications and runs in
parallel with a FOA of identical scientific scope, RFA-RR-08-003,
that solicits applications under
the Small Business Innovation Research (SBIR) (R43/R44) grant mechanisms.

Funds Available and Anticipated
Number of Awards. The participating organization(s) NCRR, NIGMS and NICHD intend to commit approximately
$400,000 dollars in FY 2009to fund one to four (1-4)Phase I, Phase II, or Fast
Track applications under the STTR set-aside funding mechanism. Awards
issued under this FOA are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.

Budget and Project Period.Phase I awards normally may not
exceed $100,000 total for a period normally not to exceed 1 year. Phase II
awards normally may not exceed $750,000 total for a period normally not to
exceed 2 years. These award levels and project periods are statutory
guidelines, not ceilings. Therefore, applicants are encouraged to propose a
budget and project duration period that is reasonable and appropriate for
completion of the research project. Phase II competing renewal budgets must be submitted in
accordance with participating IC-specific budget limitations described in the PHS 2008-2 SBIR/STTR Program
Descriptions and Research Topics.

Eligible Institutions/Organizations: Only United States SBCs are
eligible to submit STTR applications. A SBC is one that, on the date of
award for both Phase I and Phase II funding agreements, meets ALL of the
criteria as described in Section III.

Eligible Project Directors/Principal Investigators: Individuals with
the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their organization to develop an
application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. On an STTR application, the PD/PI may be employed with
the SBC or the participating non-profit research institution as long as
he/she has a formal appointment with or commitment to the applicant SBC,
which is characterized by an official relationship between the small
business concern and that individual.

Number of PDs/PIs. More than one PD/PI,
(i.e., multiple PDs/PIs), may be designated on the application.

Number of Applications: Applicant SBCs may
submit more than one application, provided each application is
scientifically distinct.

Resubmissions.Unfunded
applications previously submitted to RFA-RR-07-008 may resubmit to this
reissued FOA; however, such applications must include an Introduction
addressing the previous peer review critiques (Summary Statement).

Renewals.Only NIH Phase II STTR awardees are eligible to submit a competing
renewal application. Renewal
applications will be permitted for this FOA.

Tools for germplasm cryopreservation have become
increasingly important in enabling repositories to meet the needs for
establishing banks of animal germplasm for current and future research needs.
This funding opportunity announcement (FOA) solicits applications from small
business concerns (SBCs) for Small Business Technology Transfer (STTR) projects
that propose innovative research in the areas of animal germplasm
cryopreservation methods, reagents, equipment, biosecurity, and the detection
of disease, including the vertical transmission of disease.

The ability to produce transgenic,
knockout, and mutant stocks has provided biomedical researchers with many
useful animal models for the study of human diseases. However, the
requirements to maintain these and other strains as live animals can overwhelm
the capacity of even the largest stock centers. The number of strains is so
great that it has become impossible in terms of cost, space, and manpower to
maintain more than a fraction of them as breeding colonies. Consequently, an
increasing proportion of animals are being maintained by cryopreservation of
their germplasm. However, ongoing and
planned large scale mutant and screening projects have increased the need
for efficient and efficacious technologies that can address the current and future
needs of repositories; namely, to preserve animal germplasm and more
efficiently manage and distribute animals and related biological materials.

In April 2007, a NIH workshop
entitled, Achieving High Throughput Repositories for Biomedical Germplasm Preservation
(Cryopreservation
Workshop report) was held to assess the need for cryopreservation of the large
numbers of genetically-engineered animals from multiple species that have been
created, or will be created, as a result of NIH Roadmap and Trans-NIH
initiatives, such as the Knockout Mouse Project, Target-Selected Mutagenesis in
Zebrafish, and Neuromouse Project. At that meeting, the status of germplasm
cryopreservation and drying technologies was assessed for animal models for
translational research. A major recommendation at that meeting is to encourage
the development of high-throughput and scaleable technologies for germplasm
collection, evaluation, processing and cryopreservation to shorten and refine
the processes to meet the research community needs for high-quality animal
germplasm preservation.

To help address this recommendation,
the National Center for Research Resources (NCRR), the National Institute of
General Medical Sciences (NIGMS) and the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD) invites applications
from small business concerns (SBCs) for Small Business Technology Transfer
(STTR) to develop tools to enhance cryopreservation technologies for the
preservation of, and secure long-term maintenance of sperm, embryos, oocytes,
and other forms of, laboratory animal germplasm. Examples of such research may
include but are not limited to; 1) new storage devices that enhance long-term
viability; 2) specialized reagents to improve cryopreservation, vitrification
and drying of germplasm; 3) reagents to test for germplasm viability; 4)
machinery to reduce the variability of the quality of sperm, embryos and
oocytes during collection, processing, storage and reanimation; 5) research
tools to reduce or eliminate the large individual male-to-male variability with
respect to the quality of collected sperm and survival following
cryopreservation; and 6) improved biosecurity tools for the screening,
diagnosis and elimination of selected diseases of laboratory animals, including
vertical and horizontal transmission. The target species for this FOA include,
but are not limited to, rodents, nonhuman primates, and aquatic models used in
biomedical research.

This funding opportunity
will use the Small Business Technology Transfer (STTR [R41/R42] grant
mechanisms.Applications may be submitted
for support as Phase I, Phase II, or Fast-Track grants as described in the SF424
(R&R) SBIR/STTR Application Guide. Applications for Phase II
Competing Renewal grants may be submitted.

Small
business concerns (SBCs) that have received a Phase I STTR grant may apply for
Phase II funding of that project. The Phase II must be a logical extension of
the Phase I research but not necessarily as a Phase I project supported in
response to this funding opportunity. Phase II applications will compete with
all STTR applications and will be reviewed according to the customary peer
review procedures.

The Project Director/Principal Investigator (PD/PI) will
be solely responsible for planning, directing, and executing the proposed project.

This
funding opportunity uses “Just-in-Time” information concepts. The modular
budget format is not accepted for STTR grant applications. Applicants must
complete and submit budget requests using the SF424 Research and Related
(R&R) Budget component found in the application package attached to this
FOA in Grants.gov/Apply.All
other participating organizations, including the single, “partnering” research
institution, must complete and submit requests using the Research & Related
Subaward Budget Attachment(s) Form contained in the application package.

2. Funds Available

The estimated amount of funds available for support of 4projects awarded as a result of
this announcement is $400,000 for
fiscal year 2009.Future year amounts will depend on annual
appropriations.

The
SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines
of funding support and project duration periods for Phase I and Phase II STTR
awards. Phase I awards normally may not exceed $100,000 total for
a period normally not to exceed 1 year. Phase II awards normally may not exceed
$750,000 total for a period normally not to exceed 2 years. Therefore,
applicants are encouraged to propose a budget and project duration period that
is reasonable and appropriate for completion of the research project. Phase II
competing renewal budgets must be submitted in accordance with participating
IC-specific budget limitations described in the PHS 2008-2 SBIR/STTR Program Descriptions and Research Topics.

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.

NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards made in response
to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only United States small business concerns (SBCs) are eligible to submit STTR applications. A
small business concern is one that, at the time of award for both Phase I and
Phase II STTR awards, meets all of the following criteria:

1. Organized for
profit, with a place of business located in the United States, which operates
primarily within the United States or which makes a significant contribution to
the United States economy through payment of taxes or use of American products,
materials or labor;

2. In the legal form of
an individual proprietorship, partnership, limited liability company,
corporation, joint venture, association, trust or cooperative, except that
where the form is a joint venture, there can be no more than 49 percent
participation by business entities in the joint venture;

3. At least 51 percent
owned and controlled by one or more individuals who are citizens of, or
permanent resident aliens in, the United States.

4. Has, including its
affiliates, not more than 500 employees and meets the other regulatory
requirements found in 13 C.F.R. Part 121. Business concerns, other than
investment companies licensed, or state development companies qualifying under
the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are
affiliates of one another when either directly or indirectly, (a) one concern
controls or has the power to control the other; or (b) a third-party/parties
controls or has the power to control both.

Control can
be exercised through common ownership, common management, and contractual
relationships. The term "affiliates" is defined in greater detail in
13 CFR 121.103. The term "number of employees" is defined in 13 CFR
121.106.

A business
concern may be in the form of an individual proprietorship, partnership,
limited liability company, corporation, joint venture, association, trust, or
cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small
Business Administration's (SBA) Government Contracting Area Office or Office of
Size Standards.

One of the
circumstances that would lead to a finding that an organization is controlling
or has the power to control another organization involves sharing common office
space and/or employees and/or other facilities (e.g., laboratory space). Access
to special facilities or equipment in another organization is permitted (as in
cases where the awardee organization has entered into a subcontractual
agreement with another organization for a specific, limited portion of the research
project). However, research space occupied
by an STTR awardee organization must be space that is available to and under
the control of the STTR awardee for the conduct of its portion of the proposed
project.

Title
13 CFR 121.3 also states that control or the power to control exists when “key
employees of one concern organize a new concern ... and serve as its
officers, directors, principal stockholders, and/or key employees, and one
concern is furnishing or will furnish the other concern with subcontracts,
financial or technical assistance, and/or other facilities, whether for a fee
or otherwise.” Where there is indication of sharing of common employees, a
determination will be made on a case-by-case basis of whether such sharing
constitutes control or the power to control.

For
purposes of the STTR program, personnel obtained through a Professional
Employer Organization or other similar personnel leasing company may be
considered employees of the awardee. This is consistent with SBA’s size
regulations, 13 CFR 121.106 – Small Business Size Regulations.

All
STTR grant applications will be
examined with the above eligibility considerations in mind. If it appears that
an applicant organization does not meet the eligibility requirements, NIH will
request a size determination by the SBA. If eligibility is unclear, NIH will
not make an STTR award until the SBA provides a determination.

Note:
An applicant organization that has been determined previously by SBA to be
“other than small” for a size standard of not more than 500 employees or for
purposes of the SBIR/STTR program, must be recertified by the SBA prior to any
future SBIR/STTR awards.

1.B.
Eligible Individuals

Any
individual(s) with the skills, knowledge, and resources necessary to carry out
the proposed research as the PD/PI is invited to work with his/her organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

More
than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application
for projects that require a “team science” approach and therefore clearly do
not fit the single-PD/PI model. Additional information on the implementation plans and policies
and procedures to formally allow more than one PD/PI on individual research
projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be registered in the NIH electronic
Research Administration (eRA) Commons prior to the submission of the
application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. The NIH review criteria for
approach, investigators, and environment have been modified to accommodate
applications involving either a single PD/PI or multiple PDs/PIs. When
considering the multiple PD/PI option, please be aware that the structure and
governance of the PD/PI leadership team as well as the knowledge, skills and
experience of the individual PDs/PIs will be factored into the assessment of
the overall scientific merit of the application. Multiple PDs/PIs on a project
share the authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating organization,
for the proper conduct of the project or program, including the submission of
required reports. For further information on multiple PDs/PIs, please seehttp://grants.nih.gov/grants/multi_pi.

For
a STTR application, the PDs/PIs may be employed with the SBC or the single,
“partnering” non-profit research institution as long as s/he has a formal
appointment with or commitment to the applicant SBC, which is characterized by
an official relationship between the SBC and that individual.

As defined
in 42 CFR 52, the PD/PI is the “single individual designated by the grantee in
the grant application … who is responsible for the scientific and technical
direction of the project.” When the proposed PD/PI clearly does not have
sufficient qualifications to assume this role, the application is not likely to
receive a favorable evaluation.

Each PD/PI
must commit a minimum of 10% effort to the project and the PD/PI must have a
formal appointment with or commitment to the applicant small business concern,
which is characterized by an official relationship between the small business
concern and that individual. Such a relationship does not necessarily involve a
salary or other form of remuneration. In all cases, however, the PD/PI’s
official relationship with the grantee must entail sufficient opportunity for
the PD/PI to carry out his or her responsibilities for the overall scientific
and technical direction of the project. Documentation
(e.g., consultant, consortium and contractual arrangements) describing the
official relationship of the PD/PI with the applicant small business concern
should NOT be submitted with the grant application, but a copy must be
furnished upon the request of the NIH awarding component.

The
following are examples of situations describing the official relationship of
the PD/PI with the applicant small business organization:

PD/PI with a full-time, university appointment may also have
appointments with other organizations (with or without salary) and still
appropriately consider his or her commitment to the university to be
“full-time,” consistent with the personnel policies and procedures of the
university applied on a routine basis. The PD/PI’s commitment to the university
and other organizations (including the applicant small business concern) cannot
exceed 100% of his or her total professional effort.

PD/PI with a full-time, 12-month appointment with a small
business concern would be considered to have a commitment to the applicant organization
of 100% of his or her total professional effort.

PD/PI who has a part-time appointment with a small business
concern and has concurrent commitments or appointments with organizations in
addition to the small business concern would deem each commitment as a portion
of 100% of his or her total professional effort.

In
STTR Phase I and Phase II, at least 40% of the work must be performed by the
small business concern and at least 30% of the work must be performed by the
single, “partnering” research institution. The basis for determining the
percentage of work to be performed by each of the cooperative parties will be
the total of direct and F&A/indirect costs attributable to each party,
unless otherwise described and justified in Item 12, “Consortium/Contractual
Arrangements,” of the PHS398 Research Plan component of the SF424 (R&R)
application forms.

Applicants may submit more than one
application, provided each application is scientifically distinct.

The
NIH will accept as many "different" applications as the applicant
organization chooses. However, the NIH will not accept similar grant
applications with essentially the same research focus from the same applicant
organization. This includes derivative or multiple applications that propose to
develop a single product, process, or service that, with non-substantive
modifications, can be applied to a variety of purposes. Applicants may not
simultaneously submit identical/essentially identical applications under both
this funding opportunity and any other HHS FOA, including the current SBIR or
STTR Parent FOAs.

It is unlawful to enter into
contracts or grants requiring essentially equivalent work or effort.
“Essentially equivalent work or effort” occurs when (1) substantially the same
research is proposed for funding in more than one contract proposal or grant
application submitted to the same Federal agency; (2) substantially the same
research is submitted to two or more different Federal agencies for review and
funding consideration; or (3) a specific research objective and the research
design for accomplishing an objective are the same or closely related in two or
more proposals or awards, regardless of the funding source. If there is any
question concerning essentially equivalent work or effort, it must be disclosed
to the soliciting agency or agencies before award.

Only one Phase II award
may be made for a single SBIR/STTR project.

You
may submit a Phase II application either before or after expiration of the
Phase I budget period, unless you elect to submit a Phase I and Phase II
application concurrently under the Fast-Track procedure. To maintain
eligibility to seek Phase II support, a Phase I grantee organization should
submit a Phase II application within the first six due dates following the
expiration of the Phase I budget period.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
Application Guide for completing the SF424 (R&R) forms for this FOA, use
the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual(s) designated as PD/PIs
on the application must also be registered in the NIH eRA Commons. In the case of multiple
PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application. It is not necessary for PDs/PIs
to register with Grants.gov.

Each
PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however,
if they have both a PD/PI role and an Internet Assisted Review (IAR) role,
both roles should exist under one Commons account.

When
multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. When PDs/PIs are located
at another institution, only the contact PI (the PI named on the SF424
(R&R) Cover) must be affiliated with the applicant small business
concern; other PD/PIs need not be affiliated with the applicant
organization, but must be affiliated with their own organization to be
able to access the Commons.

This
registration/affiliation must be done by the AOR/SO or their designee who
is already registered in the Commons.

Both the
PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an
Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their institution is already
registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR
Application Guide for this FOA using the “Apply for Grant Electronically”
button in this FOA or through Grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

Prepare all STTR
applications using the SF424 (R&R) application forms and the SF424
(R&R) SBIR/STTR Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) SBIR/STTR
Application Guide is critical to submitting a complete and accurate application
to NIH. There are fields within the SF424 (R&R) application components
that, although not marked as mandatory, are required by NIH (e.g., the
Commons ID of each PD/PI must be included in the “Credential” field of the
Research & Related Senior/Key Person component.)Failure to
include this data field will cause the application to be rejected. Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see “Frequently Asked Questions – Application
Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R)
application is comprised of data arranged in separate components. Some
components are required, others are optional. The forms package associated with
this FOA in Grants.gov/ APPLY will include all applicable components, required and
optional. A completed application in response to this FOA will include the
following components:

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PD/PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The Contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above. All funding for STTR projects goes to the
small business concern, so funding for PD/PIs from other organizations must be
requested via a subcontract with the small business using the Research &
Related Subaward Budget Attachment(s) Form.

Information
for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
“PD/PI.” Please remember that all PDs/PIs must be registered in the
eRA Commons prior to application submission. The Commons ID of each
PD/PI must be included in the “Credential” field of the Research & Related
Senior/Key Person component. Failure to include this data field will cause
the application to be rejected.

All
projects proposing Multiple PDs/PIs will be required to include a new section
describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple
PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI
Leadership Plan” (Section 14 of the Research Plan Component in the SF424
(R&R)), must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, including
communication plans, process for making decisions on scientific direction, and
procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the project or program should be
delineated for the PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award (NoA).

Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application submission/receipt
date(s). (See Section IV.3.A. for all dates.) If an
application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted
through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the application
image to determine if any further action is necessary.

If everything is acceptable, no
further action is necessary. The application will automatically
move forward to the Division of Receipt and Referral in the Center for
Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior to the submission deadline, the
AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This option
should be used if it is determined that some part of the application was
lost or did not transfer correctly during the submission process, the
AOR/SO will have the option to “Reject” the application and submit a
Changed/Corrected application. In
these cases, please contact the eRA Help Desk to ensure that the issues
are addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12, including the
requirement for cover letters on late applications. The
“Reject” feature should also be used if you determine that warnings are
applicable to your application and need to be addressed now. Remember,
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two weekdays if no action is taken. Some warnings may
need to be addressed later in the process.

If the two-day window falls after
the submission deadline, the AOR/SO will have the option to “Reject” the
application if, due to an eRA Commons or Grants.gov system issue, the
application does not correctly reflect the submitted application package
(e.g., some part of the application was lost or didn’t transfer correctly
during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm
the system error, document the issue, and determine the best course of
action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject”
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be
submitted but it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will
receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two days.

Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review (CSR) and responsiveness by the NCRR. Incomplete and
non-responsive applications will not be reviewed.

There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. However, when a previously
unfunded application, originally submitted as an investigator-initiated application,
is to be submitted in response to a funding opportunity, it is to be prepared
as a NEW application.

This
does not preclude the submission of an application already reviewed with
substantial changes, but such application must include an “Introduction”
addressing the previous critique. Note such an application is considered a
resubmission.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH
Grants Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing renewal award.

The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See the NIH
Grants Policy Statement.

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see “Frequently Asked Questions –
Application Guide, Electronic
Submission of Grant Applications.”

PHS398 Research Plan Component Sections

While
each section of the Research Plan component needs to be uploaded separately as
a PDF attachment, applicants are encouraged to construct the Research Plan
component as a single document, separating sections into distinct PDF
attachments just before uploading the files. This approach will enable
applicants to better monitor formatting requirements such as page limits. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be
used.

All application
instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to
be followed, with the following requirements.

STTR
Phase I applications:

Although preliminary data are not required, they may be
included.

Items 2-5 of the Research Plan component may not exceed
15 pages, including tables, graphs, figures, diagrams, and charts.

The Biographical Sketch is limited to a maximum of four (4) pages for each
senior/key person. (This includes the table at the top of the first page).

There is
no further limitation on the total number of pages for the entire Phase I
application; however, applicants are encouraged to be succinct.

STTR
Phase II applications:

Items 2-5 of the Research Plan component may not exceed 25 pages,
including tables, graphs, figures, diagrams, and charts.

The Biographical Sketch is limited to a maximum of four (4) pages for each
senior/key person. (This includes the table at the top of the first page.)

The Phase II application must present a Commercialization Plan
(maximum 15 pages) that addresses specific points as described in the SF424 (R&R)
SBIR/STTR Application Guide and the SBIR/STTR Information component.

There is no further limitation on the total number of pages for
the entire Phase II application; however, applicants are encouraged to be
succinct.

STTR
Fast-Track applications:

The NIH Fast-Track application is a single application consisting
of Phase I and Phase II activities. See section on “Fast-Track Applications” in
the SF424 (R&R) SBIR/STTR Application Guide.

The Phase I portion of a Fast-Track must specify clear,
measurable goals (milestones) that should be achieved prior to initiating Phase
II work.

The Fast-Track application must present a Commercialization Plan
(maximum 15 pages) that addresses specific points as described in the SF424
(R&R) SBIR/STTR Application Guide.

Items 2-5 of the Research Plan component may not exceed 25 pages.
That is, the combined Phase I and Phase II plans for Fast-Track applications
(for Items 2-5) must be contained within the 25-page limitation.

Resubmissions:

Resubmissions must include an Introduction
addressing the previous peer review critique (Summary Statement).

Introductions are limited to one
page for Phase I and three pages for Phase II submissions.

Warning: Please be sure that you observe the total cost,
project period, and page number limitations specified above for this FOA.
Application processing may be delayed or the application may be rejected if it
does not comply with these requirements.

Do not use the Appendix to circumvent the page
limitations of the Research Plan component. An application that does not
observe the required page limitations may be delayed in the review process.
Phase I SBIR/STTR Appendix materials are not permitted unless specifically
requested by NIH.

Resource Sharing
Plan(s)

NIH considers
the sharing of unique research resources developed through NIH-sponsored
research an important means to enhance the value and further the advancement of
the research. When resources have been developed with NIH funds and the
associated research findings published or provided to NIH, it is important that
they be made readily available for research purposes to qualified individuals
within the scientific community. If the final
data/resources are not amenable to sharing, this must be explained in the
Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications in which the development
of model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible (see Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount
requested, applicants seeking funding for a genome-wide association
study are expected to provide a plan for submission of GWAS data to the
NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (e.g., blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy
for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies(NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2.
Review and Selection Process

Applications that are complete and responsive to
this FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by CSRand in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As
part of the initial merit review, all applications will:

Undergo a
selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.

Receive a
written critique.

Receive a
second level of review by the appropriate national advisory council or
board.

Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following
will be considered in making funding decisions:

Scientific
merit of the proposed project as determined by peer review.

Availability
of funds.

Relevance
of the proposed project to program priorities.

The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a meritorious priority score.

Applicants should include information in relevant sections of the
grant application that addresses the questions for each review criterion below.

All STTR Applications

Significance: Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge or clinical practice be advanced?
What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field? Does the application lead to enabling technologies (e.g.,
instrumentation, software) for further discoveries? Will the technology have a
competitive advantage over existing/alternate technologies that can meet the
market needs? Does the proposed project have commercial potential to lead to a
marketable product, process or service? What may be the anticipated commercial
and societal benefits that may be derived from the proposed research?

Approach: Are
the conceptual or clinical framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Does
the applicant acknowledge potential problem areas and consider alternative
tactics? For applications designating multiple PD/PIs, is the leadership
approach, including he designated roles and responsibilities governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PD/PIs? Is the proposed plan a sound
approach for establishing technical and commercial feasibility? Are the
milestones and evaluation procedures appropriate?

Innovation: Is
the project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?

Investigator(s): Are the PD/PI(s) and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the PD/PI(s) and other researchers,
including consultants and subcontractors (if any)? Do the PD/PIs and
investigative team bring complementary and integrated expertise to the project
(if applicable)? Are the relationships of the key personnel to the small
business and to other institutions appropriate for the work proposed?

Environment: Do(es) the scientific and technological environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support? Is there sufficient access to resources (e.g., equipment, facilities)?

Special review criteria: For the purpose of
this FOA, “Significance” of the proposed laboratory animal species will be
based on the project’s impact on biomedical research. Applications proposing
research projects involving predominantly agricultural or farm animals will be
considered lower priority.

Phase
II Applications

In
addition to the above review criteria:

1. How well
did the applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?

2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?

3. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?

Phase
I/Phase II Fast-Track Application Review Criteria

For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:

1. Does the
Phase I application specify clear, appropriate, measurable goals (milestones)
that should be achieved prior to initiating Phase II?

2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?

3.
To what extent was the applicant able to obtain letters of interest, additional
funding commitments, and/or resources from the private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?

4. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?

Phase I and
Phase II Fast-Track applications that satisfy all of the review criteria will
receive a single rating.

For
Fast-Track applications, the Phase II portion may not be funded until a Phase I
final report and other documents necessary for continuation have been received
and assessed by program staff that the Phase I milestones have been
successfully achieved. Items 2-5 of the Research Plan may not exceed 25 pages.
That is, the combined Phase I and Phase II plans for a Fast-Track application (for
Items 2-5) must be contained within the 25-page limitation.

Phase II
Competing Renewal Applications

In addition
to the above review criteria described under “All STTR Applications,” the
following items will be applied to ALL Phase II competing renewal applications
in the determination of scientific merit and the rating.

2.
Did the applicant submit a concise Commercialization Plan that adequately addresses
the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide
and the SBIR/STTR Information component?

3.
Does the project carry a high degree of commercial potential as described in
the Commercialization Plan?

2.A.
Additional Review Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Resubmission
Applications (formerly “revised/amended” applications): Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See item 6 of the Research Plan
component of the SF424 (R&R).

Inclusion of Women, Minorities and
Children in Research: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research will be assessed. Plans
for the recruitment and retention of subjects will also be evaluated. See item
7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget and Period of
Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. The priority score should not be affected
by the evaluation of the budget.

2.C. Resource Sharing
Plan(s)

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of scientific
merit or priority score, unless noted otherwise in the FOA. Program staff
within the IC will be responsible for monitoring the resource sharing.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section
IV.5., “Funding Restrictions.”

A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official.

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects
Protection:Federal regulations
(45 CFR 46) require that applications and proposals involving human subjects
must be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (“NIH Policy for
Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators should seek guidance from their
institutions, on issues related to institutional policies and local
institutional review board (IRB) rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model organisms
for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH funding
or state why such sharing is restricted or not possible. This will permit other
researchers to benefit from the resources developed with public funding. The
inclusion of a model organism sharing plan is not subject to a cost threshold
in any year and is expected to be included in all applications where the
development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, Internet addresses (URLs) or
PubMed Central (PMC) submission identification numbers must be used for
publicly accessible on-line journal articles. Publicly accessible on-line
journal articles or PMC articles/manuscripts accepted for publication that are
directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the number
of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.